NA 02.127.180Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982043382), received between Nov 15, 2019 and Apr 27, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6) 2022 TO IMPLANT THE DEVICE. ON (B)(6) 2023, IT APPEARED THAT THE PATIENT HAD DEVELOPED A REACTION ISSUE WITH THE TITANIUM IN HIS LOWER LEG. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 11 OF 11 FOR (B)(4). THIS REPORT INVOLVES ONE (1) 3.5 VA LCKNG SCR SLF-TPNG/SD/80

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16825215 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AROUND (B)(6) 2020 THE PATIENT FELL FROM A SCAFFOLDING AND INJURED HIS RIGHT KNEE. THE CT SCAN REVEALED A COMMINUTED BICONDYLAR TIBIAL PLATEAU FRACTURE. AROUND (B)(6) 2020 THE PATIENT UNDERWENT RIGHT TIBIAL ORIF WITH MEDIAL POSTEROMEDIAL PLATING, MEDIAL AND LATERAL MENISCAL REPAIR AND A PROPHYLACTIC 4 COMPARTMENT FASCIOTOMY. THE SURGEON IMPLANTED A PROXIMAL ANTEROLATERAL SYNTHES TIBIAL PLATEAU LOCKING PLATE AND ONE 3.5 POSTEROMEDIAL TIBIAL T PLATE WITH ASSOCIATED SCREWS. THE SURGEON ALSO UTILIZED A SINGLE-USE DRILL BIT. FOLLOWING THE SURGERY OF (B)(6) 2020 THE PATIENT PERFORMED REHABILITATION AND THERAPY AS RECOMMENDED BY HIS MEDICAL PROVIDERS. HOWEVER, HE CONTINUED TO EXPERIENCE PAIN, DISCOMFORT, AND FUNCTIONAL LIMITATIONS IN HIS RIGHT KNEE. ALSO HE EXPERIENCED PROBLEMS WITH WOUND HEALING, INCLUDING INCREASED PAIN, SWELLING, AND DRAINAGE FROM THE INCISION SITE. AROUND (B)(6) 2020 THE PATIENT DIAGNOSED WITH SEPTIC ARTHRITIS. IT WAS DETERMINED THAT THE PATIENT WOULD UNDERGO ADDITIONAL SURGERY FOR HIS WOUND COMPLICATIONS, INCLUDING ARTHROSCOPIC IRRIGATION AND DEBRIDEMENT OF HIS MEDIAL AND LATERAL INCISIONS ALONG WITH THE REMOVAL OF ALL HIS HARDWARE AND THE INSTAL

  Patient problems: Discomfort; Impaired Healing; Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16751157 ↗
• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022, THAT THERE WAS REMOVAL OF HARDWARE AND REVISION. NON UNION RIGHT FEMUR. ALL HARDWARE WAS REMOVED WITHOUT COMPLICATION. THERE WERE NO BROKEN IMPLANTS. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS DOING WELL AFTER POST OP. THIS REPORT IS FOR ONE (1) 3.5 VA LCKNG SCR SLF-TPNG/SD/80. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14998922 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SALES CONSULTANT WAS NOTIFIED OF AN ADD ON CASE. THE PATIENT HAD A COMPLAINT TO BE SEEN AFTER A TIBIA PLATEAU FRACTURE AND REPAIR DUE TO SEVERE PAIN AND OTHER COMPLICATIONS. THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) OF 2021 AND THE PATIENT HAD A DRAINING FISTULA AT THE INCISION SITE AS WELL AS IMPROPER REDUCTION OF THE ORIGINAL FRACTURE. THE SURGEON DECIDED TO REMOVE ALL CURRENT HARDWARE AND VERIFY THE PRESENCE OR THE LACK OF PATHOGENS. ALSO THE PATIENTS HEALTH NEEDS TO BE STABLE BEFORE HE CAN PROCEED WITH A REVISION SURGERY, TO PROPERLY REDUCE THE JOINT LINE AND MAKE THE LIMB USEABLE AGAIN FOR THE PATIENT. THIS REPORT IS FOR ONE (1) 3.5 VA LCKNG SCR SLF-TPNG/SD/80. THIS IS REPORT 12 OF 18 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12797605 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON OCTOBER 18 2021, THE SALES CONSULTANT WAS NOTIFIED OF AN ADD ON CASE. THE PATIENT HAD A COMPLAINT TO BE SEEN AFTER A TIBIA PLATEAU FRACTURE AND REPAIR DUE TO SEVERE PAIN AND OTHER COMPLICATIONS. THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) OF 2021 AND THE PATIENT HAD A DRAINING FISTULA AT THE INCISION SITE AS WELL AS IMPROPER REDUCTION OF THE ORIGINAL FRACTURE. THE SURGEON DECIDED TO REMOVE ALL CURRENT HARDWARE AND VERIFY THE PRESENCE OR THE LACK OF PATHOGENS. ALSO THE PATIENTS HEALTH NEEDS TO BE STABLE BEFORE HE CAN PROCEED WITH A REVISION SURGERY, TO PROPERLY REDUCE THE JOINT LINE AND MAKE THE LIMB USEABLE AGAIN FOR THE PATIENT. THIS REPORT IS FOR (1) 3.5 VA LCKNG SCR SLF-TPNG/SD/80. THIS IS REPORT 11 OF 18 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12797537 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SALES CONSULTANT WAS NOTIFIED OF AN ADD ON CASE. THE PATIENT HAD A COMPLAINT TO BE SEEN AFTER A TIBIA PLATEAU FRACTURE AND REPAIR DUE TO SEVERE PAIN AND OTHER COMPLICATIONS. THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2021 AND THE PATIENT HAD A DRAINING FISTULA AT THE INCISION SITE AS WELL AS IMPROPER REDUCTION OF THE ORIGINAL FRACTURE. THE SURGEON DECIDED TO REMOVE ALL CURRENT HARDWARE AND VERIFY THE PRESENCE OR THE LACK OF PATHOGENS. ALSO THE PATIENTS HEALTH NEEDS TO BE STABLE BEFORE HE CAN PROCEED WITH A REVISION SURGERY, TO PROPERLY REDUCE THE JOINT LINE AND MAKE THE LIMB USEABLE AGAIN FOR THE PATIENT. THIS REPORT IS FOR ONE (1) 3.5 VA LCKNG SCR SLF-TPNG/SD/80. THIS IS REPORT 3 OF 18 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12796619 ↗
• MalfunctionNov 15, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT THE HEAD OF THE SCREW APPEARS TO BE DEFORMED AND SMALLER THAN THE REST OF THE SCREWS. IT ALSO HAS A SHARP NICK IN BEDDED IN THE THREADS THAT WAS PRESENT PRIOR TO ATTEMPTING TO PUT THE SCREW IN THE PLATE. THE SURGEON COMMENTED THAT THE SCREW WENT THROUGH THE PLATE WITH NO RESISTANCE. HE TRIED PUTTING IT IN A ANOTHER PLATE ON THE BACK TABLE AND THE SAME THING HAPPENED, THE SCREW WENT DIRECTLY THROUGH THE PLATE WITHOUT LOCKING INTO IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9328461 ↗